6361 Device & Packaging Development – Lab Technical Specialist
Description:
Perform physical and analytical testing of medical devices and combination products for R&D, verification, complaints, and stability programs.
Perform laboratory testing in a cGMP environment and understand the technical and compliance needs of the business.
Actively participate in continuous improvement to maintain the company’s right to operate, supply to patients, and cost-effectiveness.
Job Responsibilities:
Leadership:
Create an environment of strong team spirit with timely and effective communications.
Develop an ability to influence using technical and personal reasoning.
Technical:
Perform a broad variety of basic and moderately complex tests in support of lab operations.
Perform testing of routine and non-routine samples and documents according to cGMPs.
Perform routine lab maintenance.
Prepare basic and complex reagents as assigned.
Order and maintain a lab supply inventory.
Perform sample filling and decontamination, and assist in lab complaints investigations.
Receive and provide training.
Participate in method transfer and validation.
Perform equipment qualification/maintenance as assigned.
Coordinate with lab supervisor to support operational activities.
Identify and support the resolution of technical problems.
Actively participate in group and project teamwork; project and process improvements.
Resolve issues as needed with management approval.
Adhere to cGMP policies and procedures, including documentation activities.
Meets the scheduled performance of 95% on time.
Perform other duties as requested by supervisor/manager to support Quality.
Job Requirements:
Education:
Require a minimum of an associate degree (AA) (preferably in a relevant scientific discipline) or an equivalent combination of education and experience.
Knowledge/Skills/Competencies:
Basic knowledge of scientific theories, principles, and techniques used in physical and analytical test procedures.
Ability to exercise sound judgement, reasoning and problem solving.
Capable of completing assigned responsibilities and keeping manager informed of status.
Extensive knowledge and technical understanding to complete routine and non-routine assignments.
Good verbal and written communication skills needed to accomplish assigned tasks.
Ability to work under minimal supervision to complete assigned tasks in a timely manner.
Work Environment/Physical Demands/Safety Considerations:
Work Environment:
The majority of work is completed at the location of employment in a laboratory type
setting.
Physical Demands:
Ability to make repetitive motions and manual manipulations of samples.
Must be able to lift 25 pounds.
Safety Considerations:
Work is performed in a laboratory setting.
Exposure to hazardous chemicals may occur.
Work requires use of glassware, needles, syringes and hot plates. PPE (e.g. lab coat, safety
glasses) are required whenever working in the laboratory.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.